Acute ilio-femoral vein thrombosis
Conditions
Interventions
Trade Name: Actilyse
Product Name: alteplase
Pharmaceutical Form: Intravenous infusion
Trade Name: Heparin
Product Name: heparin
Pharmaceutical Form: Intravenous infusion
Sponsors
Eastern Norway Regional Health Authority
Ullevaal University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Age 18-75 years. 2 Onset of symptoms =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Anticoagulant therapy prior to trial entry for >7 days. 2 Contraindications to thrombolytic therapy, including bleeding diathesis. 3 Indications for thrombolytic therapy, e.g., phlegmacia coerolia dolens or vena cava thrombosis. 4 Severe anemia (hemoglobin 160 mm Hg or diastolic blood pressure >100 mm Hg. 8 Pregnancy (but post-partum thrombosis may be included). 9 Less than 14 days post-surgery or post-trauma. 10 History of subarachnoidal or intracerebral bleeding. 11 Disease with life expectancy < 24 months. 12 Drug abuse or mental disease that may interfere with treatment and follow-up. 13 Former ipsilateral proximal DVT. 14 Chemotherapy/advanced malignant disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether catheter-directed thrombolytic therapy for first-time acute deep vein thrombosis of the iliofemoral veins may (1) increase patency rate of affected veins at 6 months and (2) reduce the risk of post-thrombotic syndrome at 2 years ;Secondary Objective: 1 To investigate frequency of clinically relevant bleeding related to the procedure. 2 To investigate effects on quality of life (QoL). 3 To investigate cost-effectiveness of treatment. 4 To investigate the procedural success of catheter directed thrombolysis. 5 To identify markers of importance for successful thrombolysis. 6 To investigate patency at 2 years. 7 To investigate post-thrombotic syndrome at 6, 12, 36, 48, and 60 m. 8 To investigate whether presence or absence of post-thrombotic syndrome at any time point is related to patency at end of treatment. 9 To investigate prevalence of vein anomalies (and need for angioplasty or stents). 10 To investigate prevalence of underlying thrombophilia. 11 To investigate frequency of recurrent venous thromboembolism during follow-up. 12 To identify markers of importance for recurrent thrombosis. ;Primary end point(s): Patency of affected vein(s) after 6 months and frequency of post-thrombotic syndrome after 2 years. | — |
Countries
Norway
Outcome results
None listed